Migration-related determinants of health-related quality of life of persons with direct migration background in Germany: a study based on the German Socio-Economic Panel.

Introduction: Persons with a direct migration background made up a share of around 17% of the total German population in the year 2020. Not much is known about migration-related determinants of health-related quality of life (HrQoL) of persons with direct migration background. This study aimed to analyze the associations between HrQoL, sociodemographic, and migration-related characteristics of persons with direct migration background in Germany. Methods: The sample of this study was based on four waves (2014, 2016, 2018, and 2020) of the migration samples (M1 and M2) of the German Socio-Economic Panel (SOEP). The SF-12 was used to measure HrQoL using its mental (MCS) and physical (PCS) component summary scores. Missing information was replaced by multiple imputation by chained equations with predictive mean matching. Associations between HrQoL and sociodemographic and migration-related characteristics were examined using multilevel mixed-effects linear regressions. Results: The mean MCS and PCS scores of persons with direct migration background(n = 4,124) were 51.81 and 51.57, respectively. Being born in Russia was associated statistically significantly with a lower PCS score compared with non-east European and American/Oceanic countries. A longer period since migration to Germany was negatively associated with both MCS and PCS scores (both with p < 0.01). A steady relationship before migration was associated with a higher MCS score (+0.69, p = 0.017). Not feeling German and experiencing disadvantages due to origin were negatively associated with the MCS (both with p < 0.001). The oral ability in the German language was positively associated with the PCS score (p < 0.05). Conclusion: The time since migration to Germany, and the relationship status before migration may be determinants of HrQoL of persons with a direct migration background. Furthermore, connectedness with Germany, disadvantages due to origin and oral ability in the German language, representative of integration in Germany, can be potential determinants of HrQoL. Thus, integration of persons with migration background is crucial for their mental and physical HrQoL.

Interdisciplinary, internet-based trans health care (i²TransHealth): study protocol for a randomised controlled trial.

INTRODUCTION: Living in an area with no or deficient structures for trans health care is disadvantageous for trans people. By providing an internet-based health care programme, i²TransHealth aims at reducing structural disadvantages for trans people living in areas lacking specialised care. The e-health intervention consists of video consultations and a 1:1 chat with a study therapist. Additionally, the i²TransHealth network cooperates with physicians, who especially offer crisis intervention close to the participants' place of residence. The aim of this study is to evaluate the (cost-)effectiveness of the internet-based health care programme for trans people compared with a control (waiting) group. The following research questions will be examined with a sample of 163 trans people: Does a 4-month treatment with the i²TransHealth internet-based health care programme improve patient-reported health-outcomes? Is i²TransHealth cost-effective compared with standard care from a societal or health care payers' perspective? Does the participation in and support by i²TransHealth lead to an increase of trans-related expertise in the physician network? METHODS AND ANALYSIS: In a randomised controlled trial, the outcomes of an internet-based health care programme for trans people will be investigated. In the intervention group, participants are invited to use i²TransHealth for 4 months. Participants allocated to the control group will be able to start with their transition-related care after 4 months of study participation. The primary outcome measure is defined as the reduction of psychosomatic symptoms, as assessed by the Brief Symptom Inventory-18, 4 months after using the i²TransHealth programme. Participants in both groups will undergo an assessment at baseline and 4 months after using i²TransHealth. ETHICS AND DISSEMINATION: Positive ethical approval was obtained from the Hamburg Medical Association (PV7131). The results will be disseminated to service users and their families via media, to health care professionals via professional training and meetings and to researchers via conferences and publications. TRIAL REGISTRATION NUMBER: NCT04290286. PROTOCOL VERSION: 22 December 2021 (V.1.0).

Health Care Services Utilization of Persons with Direct, Indirect and without Migration Background in Germany: A Longitudinal Study Based on the German Socio-Economic Panel (SOEP).

There is ambiguous evidence with regard to the inequalities in health care services utilization (HCSU) among migrants and non-migrants in Germany. The aim of this study was to analyze the utilization of doctors and hospitalization of persons with direct and indirect migration background as well as those without in Germany. This study was based on data of the German Socio-Economic Panel using the adult sample of the years 2013 to 2019. HCSU was measured by self-reported utilization of doctors and hospitalization. Associations between HCSU and migration background were examined using multilevel mixed-effects logistic regression and zero-truncated multilevel mixed-effects generalized linear models. The odds ratios of utilization of doctors and hospitalization for persons with direct migration background compared with persons without migration background were 0.73 (p < 0.001) and 0.79 (p = 0.002), respectively. A direct migration background was associated with a 6% lower number of doctoral visits within three months compared with no migration background (p = 0.023). Persons with direct migration background still have a lower HCSU than persons without migration background in Germany. Access to health care needs to be ensured and health policy-makers are called upon to keep focus on the issue of inequalities in HCSU between migrants and non-migrants in Germany.

Health-Related Quality of Life of Persons with Direct, Indirect and No Migration Background in Germany: A Cross-Sectional Study Based on the German Socio-Economic Panel (SOEP).

Global migration towards and within Europe remains high, shaping the structure of populations. Approximately 24% of the total German population had a migration background in 2017. The aim of the study was to analyze the association between migration background and health-related quality of life (HrQoL) in Germany. The analyses were based on 2014 and 2016 data of the German Socio-Economic Panel. Differences in sociodemographic characteristics between migrant and non-migrant samples were equal by employment of the entropy balancing weights. HrQoL was measured using the physical (PCS) and mental (MCS) component summary scores of the SF-12v2. Associations between PCS and MCS scores and migration background were examined using Student's t-test. The mean PCS and MCS scores of persons with migration background (n = 8533) were 51.5 and 50.9, respectively. Persons with direct migration background had a lower PCS score (-0.55, p < 0.001) and a higher MCS score (+1.08, p < 0.001) than persons without migration background. Persons with direct migration background differed with respect to both physical and mental HrQoL from persons without migration background in the German population. Differences in HrQoL for persons with indirect migration background had p = 0.305 and p = 0.072, respectively. Causalities behind the association between direct migration background and HrQoL are to be determined.

Economic evaluations and cost analyses in posttraumatic stress disorder: a systematic review.

BACKGROUND: Posttraumatic stress disorder is associated with a high economic burden. Costs of treatment are known to be high, and cost-effectiveness has been analysed for several treatment options. OBJECTIVE: As no review on economic aspects of posttraumatic stress disorder exists, the aim of this study was to systematically review costs-of-illness studies and economic evaluations of therapeutic treatment for posttraumatic stress disorder, and to assess their quality. METHOD: A systematic literature search was performed in March 2017 and was last updated in February 2020 in the databases PubMed, PsychInfo and NHS Economic Evaluation Database. Cost-of-illness studies and economic evaluations of treatment for posttraumatic stress disorder were selected. Extracted cost data were categorized as direct costs and indirect costs and inflated to 2015 US-$ purchasing power parities (PPP). Quality was assessed using an adapted cost-of-illness studies quality checklist, the Consensus on Health Economic Criteria list, and the questionnaire to assess relevance and credibility of modelling studies by the International Society for Pharmacoeconomics and Outcome Research. RESULTS: In total, 13 cost-of-illness studies and 18 economic evaluations were included in the review. Annual direct excess costs ranged from 512 US-$ PPP to 19,435 US-$ PPP and annual indirect excess costs were 5,021 US-$ PPP per person. Trauma-focused cognitive-behavioural therapy (+selective serotonin re-uptake inhibitor) was found to be cost-effective compared with treatment as usual and no treatment. Overall, included studies were of low and moderate quality. Studies used inappropriate economic study designs and lacked information on the economic perspective used. CONCLUSIONS: Posttraumatic stress disorder is a major public health problem that causes high healthcare costs. While trauma-focused cognitive-behavioural therapy was found to be cost-effective, further investigations regarding pharmacotherapy and other treatments are necessary.

Antecedentes: El trastorno por estrés postraumático está asociado con una alta carga económica. Se sabe que los costos de tratamiento son elevados, y su costo-efectividad ha sido analizado para varias opciones de tratamiento.Objetivo: Debido a que no existe ninguna revisión sobre los aspectos económicos del trastorno de estrés postraumático, el objetivo de este estudio fue hacer una revisión sistemática de estudios de costo de enfermedad y evaluaciones económicas del tratamiento terapéutico para trastorno por estrés postraumático, y evaluar su calidad.Métodos: Se realizó una revisión sistemática de la literatura en Marzo de 2017 y fue actualizada por última vez en Febrero 2020 en las bases de datos PubMed, PsychInfo y la Base de datos de Evaluación Económica de NHS. Se seleccionaron estudios de costo de enfermedad y evaluaciones económicas de tratamiento para trastorno por estrés postraumático. Los datos extraídos sobre los costos fueron categorizados como costos directos e indirectos y elevados al dolar estadounidense del 2015 y su Paridad de Poder Adquisitivo (PPP por sus siglas en inglés). La calidad fue evaluada usando una lista de chequeo adaptada sobre la calidad de estudios de costo de enfermedad, la lista del Consenso en Criterios de Economía de Salud, y el cuestionario para evaluar relevancia y credibilidad de estudios de modelado de la Sociedad Internacional de Farmacoeconomía e investigación de Resultados.Resultados: En total, 13 estudios de costo de enfermedad y 18 evaluaciones económicas fueron incluidas en la revisión. Los costos anuales directos en exceso oscilaron entre 512 US-$ PPP a 19,435 US-$ PPP y los costos anuales indirectos en exceso fueron de 5,021 US-$ PPP por persona. La terapia cognitivo-conductual focalizada en el trauma (+ un inhibidor selectivo de la recaptura de la serotonina) fue costo-efectiva en comparación con el tratamiento usual y con no tratar. Los estudios usaron diseños inapropiados para un estudio económico y carecían de información sobre la perspectiva económica usada.Conclusiones: el trastorno por estrés postraumático es un problema de salud pública importante que causa grandes costos en atención de salud. Si bien se encontró que la terapia cognitivo-conductual focalizada en el trauma fue costo-efectiva,se requieren investigaciones futuras en relación a la farmacoterapia y otros tratamientos.

HELP@APP: development and evaluation of a self-help app for traumatized Syrian refugees in Germany - a study protocol of a randomized controlled trial.

BACKGROUND: Syrians represent the largest group among refugees in Germany. Many of them were exposed to sequential traumatizing events including war, escape and post-migration stressors, which significantly increase the risk to develop symptoms of posttraumatic stress and other mental disorders. However, there is a lack of adequate treatment options for traumatized refugees in Germany. Moreover, their access to psychosocial care is often restricted due to legal regulation, language barriers, and unclear cost coverage. We therefore aim to develop a low-threshold supportive self-help app for Syrian refugees with posttraumatic stress symptoms. By conducting a randomized controlled trial, we further aim to evaluate the apps' efficacy, usability, acceptance, and economic health benefit/cost-effectiveness. METHODS: We will develop a modular, interactive self-help app in Arabic, which will be grounded on cognitive-behavioral models for the treatment of posttraumatic stress. Subsequently, screened positive (i.e., Syrian refugees, 18-65 years old, mild to moderate posttraumatic stress symptomatology as quantified by the Posttraumatic Stress Diagnostic Scale for DSM-5/PDS-5) participants (ideally up to n = 234) will be randomly allocated to an intervention (IG) and control group (CG), respectively. Participants in the IG will gain access to the self-help app for one month, while participants in the CG will receive psychoeducational reading material in form of a comprehensive brochure on traumatization and posttraumatic stress. Measurements are scheduled before the intervention (T0), directly after the intervention (T1, one month later) and three months after the intervention (T2). Using linear mixed effect models, we will investigate change in posttraumatic symptomatology. We will also test for changes in secondary outcomes such as depression, anxiety, and quality of life. Moreover, we will inspect the usability and user acceptance of the app. To evaluate the app in terms of its economic health benefit, the incremental cost-effectiveness ratio will be calculated. DISCUSSION: We plan to make the app freely available to the general public after evaluation. Thus, the app can help to add-on to routine care, which currently lacks sufficient and appropriate treatment options for Syrian refugees. TRIAL REGISTRATION: German Clinical Trials Register/Deutsches Register Klinischer Studien (DRKS). Registration ID: DRKS00013782 . Registered: 06th of July 2018.

Health-related quality of life measured with the EQ-5D-5L: estimation of normative index values based on a representative German population sample and value set.

BACKGROUND: The generic and preference-based instrument EQ-5D is available in a five-response levels version (EQ-5D-5L). A value set for the EQ-5D-5L based on a representative sample of the German population has recently been developed. The aim of this study was to estimate normative values of the EQ-5D-5L index for Germany, and to examine associations between the EQ-5D-5L and selected sociodemographic factors. METHODS: The analysis was based on a representative sample (n = 4998) of the German general adult population in 2014. Participants had to rate their health-related quality of life on the EQ-5D-5L descriptive system as well as on a visual analogue scale (EQ-VAS). Normative values of the EQ-5D-5L index were estimated for selected sociodemographic characteristics. For the examination of associations between EQ-5D-5L index scores and selected sociodemographic factors, multivariate regression analyses were used. RESULTS: The mean EQ-5D-5L index score of the total sample was 0.88 (SD 0.18), corresponding to an overall mean EQ-VAS score of 71.59 (SD 21.36). Female gender and increasing age were associated with a lower EQ-5D-5L index score (p < 0.001). Higher education, full-time employment and private health insurance were associated with a higher EQ-5D-5L index score (p < 0.001). CONCLUSION: This was the first study to estimate normative values of the EQ-5D-5L index for Germany based on a representative sample. The German normative values of the EQ-5D-5L are comparable to those reported for other countries. However, the mean EQ-5D-5L index score of the total sample was worse than those of the samples of studies from other countries.

Cost-effectiveness analysis of collaborative treatment of late-life depression in primary care (GermanIMPACT).

BACKGROUND: Late-life depression is a highly prevalent disorder that causes a large economic burden. A stepped collaborative care program was set up in order to improve care for patients with late-life depression in primary care in Germany: GermanIMPACT is the adaption of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) program that has already been established in primary care in the USA. The aim of this study was to determine the cost-effectiveness of GermanIMPACT compared with treatment as usual from a societal perspective. METHODS: This study is part of a 12-month bi-centric cluster-randomized controlled trial aiming to assess the effectiveness of GermanIMPACT compared with treatment as usual among patients with late-life depression. A cost-effectiveness analysis using depression-free days (DFDs) was performed. Net-monetary benefit (NMB) regressions adjusted for baseline differences for different willingness-to-pay (WTP) thresholds were conducted and cost-effectiveness acceptability curves were constructed. RESULTS: In total, n = 246 patients (intervention group: n = 139; control group: n = 107) with a mean age of 71 from 71 primary care practices were included in the analysis. After 12 months, adjusted mean differences in costs and DFDs between intervention group and control group were +€354 and +21.4, respectively. Only the difference in DFDs was significant (p = 0.022). According to the unadjusted incremental cost-effectiveness ratio, GermanIMPACT was dominant compared with treatment as usual. The probability of GermanIMPACT being cost-effective was 80%, 90% or 95% if societal WTP per DFD was ≥€70, ≥€110 or ≥€180, respectively. CONCLUSION: Evidence for cost-effectiveness of GermanIMPACT relative to treatment as usual is not clear. Only if societal WTP was ≥€180 for an additional DFD, GermanIMPACT could be considered cost-effective with certainty.

Cost-effectiveness analyses and cost analyses in castration-resistant prostate cancer: A systematic review.

BACKGROUND: Treatment of metastatic prostate cancer is associated with high personal and economic burden. Recently, new treatment options for castration-resistant prostate cancer became available with promising survival advantages. However, cost-effectiveness of those new treatment options is sometimes ambiguous or given only under certain circumstances. The aim of this study was to systematically review studies on the cost-effectiveness of treatments and costs of castration-resistant prostate cancer (CRPC) and metastasizing castration-resistant prostate cancer (mCRPC) on their methodological quality and the risk of bias. METHODS: A systematic literature search was performed in the databases PubMed, CINAHL Complete, the Cochrane Library and Web of Science Core Collection for costs-effectiveness analyses, model-based economic evaluations, cost-of-illness analyses and budget impact analyses. Reported costs were inflated to 2015 US$ purchasing power parities. Quality assessment and risk of bias assessment was performed using the Consolidated Health Economic Evaluation Reporting Standards checklist and the Bias in Economic Evaluations checklist, respectively. RESULTS: In total, 38 articles were identified by the systematic literature search. The methodological quality of the included studies varied widely, and there was considerable risk of bias. The cost-effectiveness treatments for CRPC and mCRPC was assessed with incremental cost-effectiveness ratios ranging from dominance for mitoxantrone to $562,328 per quality-adjusted life year gained for sipuleucel-T compared with prednisone alone. Annual costs for the treatment of castration-resistant prostate cancer ranged from $3,067 to $77,725. CONCLUSION: The cost-effectiveness of treatments of CRPC strongly depended on the willingness to pay per quality-adjusted life year gained/life-year saved throughout all included costs-effectiveness analyses and model-based economic evaluations. High-quality cost-effectiveness analyses based on randomized controlled trials are needed in order to make informed decisions on the management of castration-resistant prostate cancer and the resulting financial impact on the healthcare system.

Cost-effectiveness Analysis of a Stepped, Collaborative and Coordinated Health Care Network for Patients with Somatoform Disorders (Sofu-Net).

BACKGROUND: Somatoform disorders are highly prevalent mental disorders causing impairment and large economic burden. In order to improve the diagnosis and management of affected patients, a health care network for somatoform disorders (Sofu-Net) was implemented in primary care. AIMS OF THE STUDY: The aim of the study was to determine the cost-effectiveness of a stepped, collaborative and coordinated health care network for somatoform and functional disorders (Sofu-Net) compared with regular primary care physician (PCP) practices in German primary care from a societal perspective. METHODS: This study was part of a 6-month controlled, prospective, non-randomized, observer-blinded cluster cohort trial. Participants were recruited from 33 PCP practices in Hamburg, Germany. The health care network was a collaboration of PCPs, psychotherapists, inpatient clinics and a specialized outpatient clinic. Participants in the control group received usual care. A cost-effectiveness analysis, using treatment response as measure of effectiveness, was performed. Uncertainty in cost-effectiveness was analyzed using cost-effectiveness acceptability curves. RESULTS: In total, n=218 patients (n=119 patients in the intervention group and n=99 patients in the control group) were included in the study. At 6 months, patients within the Sofu-Net group did not differ significantly from the control group with regard to costs (533; standard error 941) and treatment response (--10.3%). For Sofu-Net, the probability of being cost-effective at a willingness-to-pay (WTP) of 10,000 per additional response to treatment was only 31%. DISCUSSION: Sofu-Net is unlikely to be cost-effective. Even for high WTP, the probability of cost-effectiveness was low. The results were robust to variation of costs included in the analysis as well as when only complete cases were included in the analysis. The most important limitations of the study were that randomization could not be established at patient level and at practice level and that the study design did not allow measurement of costs at baseline. CONCLUSION: Patients with severe somatic symptoms did not benefit from the health care network. Sofu-Net might have reduced costs in patients with moderate somatic symptoms. IMPLICATIONS FOR FURTHER RESEARCH: Owing to the limitations and due to a short follow-up of this study, further cost-effectiveness analyses with high methodological quality and a follow-up of at least one year are needed in order to produce results that are more reliable.

Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial).

BACKGROUND: Anxiety, depressive and somatoform disorders are highly prevalent and cause a huge economic burden. A nurse-led collaborative care intervention has been set up in order to improve self-management of patients with these mental disorders in primary care in Hamburg, Germany. The aim of this study was to determine the cost-utility of this nurse-led intervention from the health care payer perspective. METHODS: This analysis was part of a 12-month cluster-randomized controlled trial aiming to increase perceived self-efficacy of primary care patients with anxiety, depressive or somatic symptoms by collaborative nurse-led self-management support compared with routine care. A cost-effectiveness analysis using quality-adjusted life years was performed. Net-monetary benefit regressions adjusted for baseline differences for different willingness-to-pay thresholds were conducted and cost-effectiveness acceptability curves were constructed. RESULTS: In total, n = 325 patients (intervention group: n = 134; control group: n = 191) with a mean age of 40 from 20 primary care practices were included in the analysis. The adjusted differences in quality-adjusted life years and mean total costs between intervention group and control group were +0.02 and +€1145, respectively. Neither of the two differences was statistically significant. The probability for cost-effectiveness of the complex nurse-led intervention was 49% for a willingness-to-pay of €50,000 per additional quality-adjusted life year. The probability for cost-effectiveness did not exceed 65%, independent of the willingness-to-pay. CONCLUSION: The complex nurse-led intervention promoting self-management for primary care patients with anxiety, depressive or somatic symptoms did not prove to be cost-effective relative to routine care from a health care payer perspective.

Mapping the Beck Depression Inventory to the EQ-5D-3L in Patients with Depressive Disorders.

BACKGROUND: For cost-utility analyses, data on health state utilities, as provided by the EQ-5D-3L, is needed but not always available. This study specified mapping algorithms from the Beck Depression Inventory (BDI) index to the EQ-5D-3L index adjusted for specific socio-demographic variables for patients with depressive disorders. AIMS OF THE STUDY: The objective of this study was to specify mapping algorithms from the BDI index to the preference-based EQ-5D index for patients with depressive disorders, adjusting for specific socio-demographic variables. METHODS: A sample of 1,074 consecutive patients with depressive disorders from a psychotherapeutic outpatient clinic was included in the study. Standardized clinical interviews were applied to establish reliable diagnoses. For the prediction of the EQ-5D-3L index from the BDI index and selected patient socio-demographic characteristics, ordinary least squares regression with robust standard errors was used. Model prediction properties were tested using the root mean squared error and repeated random sub-sampling cross-validation. RESULTS: The BDI index predicted the EQ-5D-3L index with a significant proportion of variance explained. The highest model goodness of fit was estimated for models with the BDI index and age as independent variables. The root mean squared error of the predicted EQ-5D-3L index in the validation samples was 0.23 for all models. DISCUSSION: The mean observed EQ-5D-3L index values and the mean predicted EQ-5D-3L index values seemed not to differ between models. However, a reduction of variability using cross-validation led to those (rather) accurate mean predicted values. One limitation of this study was the restricted generalizability. Moreover, some uncertainty was introduced in model predictive performance by usage of a dependent estimation sample for validation. IMPLICATIONS FOR FURTHER RESEARCH: The specified mapping algorithms from the BDI index to the EQ-5D-3L index for patients with depressive disorders are acceptable as approximation in cost-utility analyses. A further validation in independent samples is necessary to obtain more confidence in their performance.

[Health Economic Evaluations within the Hamburg Network for Mental Health]. / Gesundheitsökonomische Evaluationen im Rahmen von psychenet.

Within the Hamburg Network for Mental Health, cost-effectiveness analyses of collaborative care models are conducted. After providing an overview of the international literature on the cost-effectiveness of collaborative care for mental disorders, this article describes the rationale, aims and methods of the cost-effectiveness analyses conducted within the Hamburg Network for Mental Health. Proof of cost-effectiveness is expected to promote the transfer of collaborative care models into routine care.

Cost-effectiveness of collaborative care for the treatment of depressive disorders in primary care: a systematic review.

BACKGROUND: For the treatment of depressive disorders, the framework of collaborative care has been recommended, which showed improved outcomes in the primary care sector. Yet, an earlier literature review did not find sufficient evidence to draw robust conclusions on the cost-effectiveness of collaborative care. PURPOSE: To systematically review studies on the cost-effectiveness of collaborative care, compared with usual care for the treatment of patients with depressive disorders in primary care. METHODS: A systematic literature search in major databases was conducted. Risk of bias was assessed using the Cochrane Collaboration's tool. Methodological quality of the articles was assessed using the Consensus on Health Economic Criteria (CHEC) list. To ensure comparability across studies, cost data were inflated to the year 2012 using country-specific gross domestic product inflation rates, and were adjusted to international dollars using purchasing power parities (PPP). RESULTS: In total, 19 cost-effectiveness analyses were reviewed. The included studies had sample sizes between n = 65 to n = 1,801, and time horizons between six to 24 months. Between 42% and 89% of the CHEC quality criteria were fulfilled, and in only one study no risk of bias was identified. A societal perspective was used by five studies. Incremental costs per depression-free day ranged from dominance to US$PPP 64.89, and incremental costs per QALY from dominance to US$PPP 874,562. CONCLUSION: Despite our review improved the comparability of study results, cost-effectiveness of collaborative care compared with usual care for the treatment of patients with depressive disorders in primary care is ambiguous depending on willingness to pay. A still considerable uncertainty, due to inconsistent methodological quality and results among included studies, suggests further cost-effectiveness analyses using QALYs as effect measures and a time horizon of at least 1 year.